Published papers

Dispensing errors pose a significant health risk, with drug name similarity being a potential contributory factor. To determine the impact of drug name similarity on dispensing errors within clinical settings, we analyzed 563 dispensing errors at an acute hospital in Japan from April 2015 to June 2018. Drug name similarity between two drugs was classified into Name-Similar and Name-Dissimilar groups using the m2-vwhtfrag index, the value of the drug name similarity. Drug efficacy similarity was categorized into Efficacy-Same, Efficacy-Close, and Efficacy-Far. The drug name similarity and drug efficacy similarity of all possible pair combinations were obtained and similarly classified. The proportion of the number of pairs with dispensing errors per the total number of drug pairs in the hospital’s drug formulary in each category was calculated. The highest proportion of the number of pairs with dispensing errors was 36% for the Efficacy-Same and Name-Similar group, and the lowest proportion was 0.022% for the Efficacy-Far and Name-Dissimilar group. The proportion of the number of pairs with dispensing errors was significantly higher in the Name-Similar category than in the Name-Dissimilar category for all drug efficacy categories. Our results indicate that drug name similarity increases the risk of dispensing errors, and that m2-vwhtfrag is a useful indicator to assess dispensing errors in clinical practice. Such drug name and efficacy similarity evaluations can help identify factors causing dispensing errors, and predict the risk of dispensing errors for newly adopted drugs, considering the relationship with the whole drug formulary in the hospital dispensary.

Exploring factors related to difficulties in extracting tablets or capsules from press-through-packages is essential for optimizing the dosage form. To achieve this, the involvement of patient insight is important. In the present study, the preferences of patients regarding drugs that are difficult to extract from their packaging were collected using an electronic medication notebook (‘harmo®’) based on dispensing data. We found that approximately 30% of respondents had difficulty removing tablets or capsules from their packaging, with 125 specific drugs identified as ‘hard to push out’. Independent factors related to ‘hard-to-push-out’ drugs were female sex and feeling of weakness in the hands or fingers. Furthermore, several ‘hard-to-push-out’ drugs had characteristics such as a spherical shape or small major axis or small major axis drug-to-pocket size ratio. The findings of this study may help improve the quality of drug packaging, thus enhancing the patients' medication experience.

Background: Many studies have identified risk factors for neutropenia associated with various chemotherapies, including gemcitabine plus nab-paclitaxel (GnP). However, few studies have focused on the delayed recovery from neutropenia, which frequently leads to treatment discontinuation. We aimed to examine whether the risk factors for neutropenia affect delayed recovery following development. Material and Methods: Data were collected from patients with pancreatic cancer who received GnP therapy between December 2014 and March 2019 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. In the present study, we investigated the following: (1) risk factors for grade 3 or higher neutropenia and (2) factors affecting delayed recovery in patients who developed neutropenia in (1). Results: Of the 638 patients who underwent GnP therapy, 364 developed neutropenia and 29 experienced delayed recovery. Most patients with delayed recovery experienced neutropenia on day 8 of the first course; therefore, we focused on this group. Among the 111 patients who developed neutropenia on day 8 of the first course, 22 experienced delayed recovery after excluding those who received granulocyte-colony stimulating factor. Low baseline neutrophil, platelet, and red blood cell counts were identified as risk factors for neutropenia. Although multivariate analysis could not be conducted due to the limited number of patients, these three factors were also associated with delayed recovery. Conclusion: Low neutrophil, platelet, and red blood cell counts at baseline were identified as risk factors for neutropenia and affecting delayed recovery.

Background: In Japan, non-pharmacists who are accredited as registered salespersons can sell over-the-counter (OTC) drugs, and they play a very important role in supporting proper OTC drug use by consumers. The purpose of this study was to evaluate information provided to and information collected from consumers, and cooperation with pharmacists during OTC drug sales by registered salespersons, and to clarify their related concerns and behaviors. Methods: A cross-sectional questionnaire-based survey of 385 registered salespersons working at 56 drugstores throughout Japan was conducted. Based on the questionnaire survey, the frequency of information provision/collection in various categories was determined for the registered salespersons. The relation between concerns of registered salespersons relating to OTC drug sales and the frequency of information provision/collection was examined. The frequency of consultation of registered salespersons with a pharmacist was calculated for registered salespersons with/without in-store pharmacists. The χ-square test or Fisher’s exact test was performed to assess the significance of differences. Results: Two hundred and seven registered salespersons (53.7%) responded completely. A greater number of OTC drug purchasers per day was associated with a greater frequency of information provision about “side effects” and information collection about “favorite items” (alcohol, tobacco, health foods, etc.) (p < 0.05). One hundred and thirty-nine (67.2%) participants had concerns about “interactions between OTC drugs and prescription drugs”, and these concerns were related to the frequency of information provision/collection (p < 0.05). Regarding the frequency of consultation with a pharmacist, 35 of 46 participants (76.1%) working with pharmacists answered “always” or “usually”, whereas only 19 of 161 participants (11.8%) working without full-time pharmacists answered “always” or “usually”. More than half of the registered salespersons thought that cooperation with a pharmacist was necessary when they were “asked about concomitant use with prescription drugs” or “told that side effects happened.” Conclusions: The results of this study show that experienced registered salespersons selling OTC drugs are more likely to collect information from consumers and to provide information to consumers. It appears to be important for registered salespersons to cooperate with pharmacists in order to provide and collect appropriate information about concomitant medications.

Background: Registered dietitians are rarely employed at community pharmacies in Japan, even though dietetic advice might benefit some patients. Objective: To clarify the present status of dietetic consultation provided by registered dietitians and their collaboration with pharmacists in community pharmacies. Methods: We conducted a cross-sectional questionnaire-based survey of pharmacists and registered dietitians who work in community pharmacies. The surveyed items were: frequency of dietetic consultation, awareness of one’s knowledge and ability to conduct dietetic consultation, concerns, pharmacists’ recognition of the need for nutritional support at community pharmacies, and cooperation between registered dietitians and pharmacists. Results: Sixty-six registered dietitians, 53 pharmacists in pharmacies with registered dietitians/dietitians, and 110 pharmacists in pharmacies without registered dietitians/dietitians responded. The frequency of dietetic consultation regarding obesity and hypertension was significantly higher for registered dietitians than for pharmacists. The ability to conduct dietetic consultation regarding diseases/conditions such as kidney disease not requiring dialysis, hyperuricemia, gout, obesity and hypertension was also significantly higher for dietitians than pharmacists. More than 70% of pharmacists recognized the importance of nutritional support at community pharmacies, while 56.1% of registered dietitians noted that they were not able to fully utilize their occupational abilities. Registered dietitians were divided into two groups: registered dietitians who answered that they were able to utilize their occupational abilities and those that answered they were not. The former group was more likely to ask pharmacists about patients’ medication for dietetic consultation and to be asked to provide dietetic consultation to patients. The latter group was more likely to find difficulty in scheduling dietetic consultation. Conclusion: Our results suggest that registered dietitians in community pharmacies have a greater explanatory ability than pharmacists concerning nutritional and dietary management for patients. It may be important for pharmacists to improve cooperation with registered dietitians by providing more opportunities for dietetic consultation.

Background: In Japan, staff who are not doctors or nurses can assist the elderly in residential care facilities to take their pre-packaged medicines. Therefore, there is a potential risk of incidents specific to staffs. The aim of this study was to clarify the causes of incidents related to medication assistance by staff in residential care facilities. Method: Semi-structured interviews with staff involved in medication incidents in long-term care facilities, focusing on how and why each incident happened, were conducted. The interview covered basic information about the subject and resident, the circumstances under which the incident had occurred, contributing factors, and countermeasures put in place. Verbatim transcripts of the interviews were prepared. Based on thematic analysis, codes and themes were created. Results: Twelve subjects participated in this study. All subjects were staffs (not doctors or nurses) in long-term care facilities. All incidents covered in this study were incidents in which the wrong resident was given the medication. The incidents arose because of “not following procedures”, such as lack of “self-check of residents’ faces/residents’ names/residents’ medicine envelopes” or “double-check with other staff” or “using a device for medication intake”. Contributory factors were grouped into four categories: individual resident factor items such as “decreased ability to understand their medication” or “refusal to take medicines”, individual staff factor items such as “lack of knowledge related to medication” or “mental burden” or “experience in medication assistance”, team factor items such as “failure to communicate with other staff”, work environment factor items such as “presence of other residents” or “other work besides medication assistance” or “not enough time” or “little understanding of fostering a safety culture at the facility”. Conclusion: This study identified four categories of contributory factors that may lead to incidents during medication assistance by caregivers for residents of care homes. These findings should be helpful for risk management in residential care facilities where staff usually provide medication assistance. Separation of meal times and medication assistance, and professional review to stagger the timing of administration of residents’ medication may be effective in reducing incidents.

Early detection and management of adverse drug reactions (ADRs) is crucial for improving patients’ quality of life. Hand-foot syndrome (HFS) is one of the most problematic ADRs for cancer patients. Recently, an increasing number of patients post their daily experiences to internet community, for example in blogs, where potential ADR signals not captured through routine clinic visits can be described. Therefore, this study aimed to identify patients with potential ADRs, focusing on HFS, from internet blogs by using natural language processing (NLP) deep-learning methods. From 10,646 blog posts, written in Japanese by cancer patients, 149 HFS-positive sentences were extracted after pre-processing, annotation and scrutiny by a certified oncology pharmacist. The HFS-positive sentences described not only HFS typical expressions like “pain" or “spoon nail”, but also patient-derived unique expressions like onomatopoeic ones. The dataset was divided at a 4 to 1 ratio and used to train and evaluate three NLP deep-learning models: long short-term memory (LSTM), bidirectional LSTM and bidirectional encoder representations from transformers (BERT). The BERT model gave the best performance with precision 0.63, recall 0.82 and f1 score 0.71 in the HFS user identification task. Our results demonstrate that this NLP deep-learning model can successfully identify patients with potential HFS from blog posts, where patients’ real wordings on symptoms or impacts on their daily lives are described. Thus, it should be feasible to utilize patient-generated text data to improve ADR management for individual patients.

Background: Patients with breast cancer have a variety of worries and need multifaceted information support. Their accumulated posts on social media contain rich descriptions of their daily worries concerning issues such as treatment, family, and finances. It is important to identify these issues to help patients with breast cancer to resolve their worries and obtain reliable information. Objective: This study aimed to extract and classify multiple worries from text generated by patients with breast cancer using Bidirectional Encoder Representations From Transformers (BERT), a context-aware natural language processing model. Methods: A total of 2272 blog posts by patients with breast cancer in Japan were collected. Five worry labels, “treatment,” “physical,” “psychological,” “work/financial,” and “family/friends,” were defined and assigned to each post. Multiple labels were allowed. To assess the label criteria, 50 blog posts were randomly selected and annotated by two researchers with medical knowledge. After the interannotator agreement had been assessed by means of Cohen kappa, one researcher annotated all the blogs. A multilabel classifier that simultaneously predicts five worries in a text was developed using BERT. This classifier was fine-tuned by using the posts as input and adding a classification layer to the pretrained BERT. The performance was evaluated for precision using the average of 5-fold cross-validation results. Results: Among the blog posts, 477 included “treatment,” 1138 included “physical,” 673 included “psychological,” 312 included “work/financial,” and 283 included “family/friends.” The interannotator agreement values were 0.67 for “treatment,” 0.76 for “physical,” 0.56 for “psychological,” 0.73 for “work/financial,” and 0.73 for “family/friends,” indicating a high degree of agreement. Among all blog posts, 544 contained no label, 892 contained one label, and 836 contained multiple labels. It was found that the worries varied from user to user, and the worries posted by the same user changed over time. The model performed well, though prediction performance differed for each label. The values of precision were 0.59 for “treatment,” 0.82 for “physical,” 0.64 for “psychological,” 0.67 for “work/financial,” and 0.58 for “family/friends.” The higher the interannotator agreement and the greater the number of posts, the higher the precision tended to be. Conclusions: This study showed that the BERT model can extract multiple worries from text generated from patients with breast cancer. This is the first application of a multilabel classifier using the BERT model to extract multiple worries from patient-generated text. The results will be helpful to identify breast cancer patients’ worries and give them timely social support.

Adverse event (AE) management is important to improve anti-cancer treatment outcomes, but it is known that some AE signals can be missed during clinical visits. In particular, AEs that affect patients’ activities of daily living (ADL) need careful monitoring as they may require immediate medical intervention. This study aimed to build deep-learning (DL) models for extracting signals of AEs limiting ADL from patients’ narratives. The data source was blog posts written in Japanese by breast cancer patients. After pre-processing and annotation for AE signals, three DL models (BERT, ELECTRA, and T5) were trained and tested in three different approaches for AE signal identification. The performances of the trained models were evaluated in terms of precision, recall, and F1 scores. From 2,272 blog posts, 191 and 702 articles were identified as describing AEs limiting ADL or not limiting ADL, respectively. Among tested DL modes and approaches, T5 showed the best F1 scores to identify articles with AE limiting ADL or all AE: 0.557 and 0.811, respectively. The most frequent AE signals were “pain or numbness”, “fatigue” and “nausea”. Our results suggest that this AE monitoring scheme focusing on patients’ ADL has potential to reinforce current AE management provided by medical staff.

Background: Early detection of adverse events and their management are crucial to improving anticancer treatment outcomes, and listening to patients’ subjective opinions (patients’ voices) can make a major contribution to improving safety management. Recent progress in deep learning technologies has enabled various new approaches for the evaluation of safety-related events based on patient-generated text data, but few studies have focused on the improvement of real-time safety monitoring for individual patients. In addition, no study has yet been performed to validate deep learning models for screening patients’ narratives for clinically important adverse event signals that require medical intervention. In our previous work, novel deep learning models have been developed to detect adverse event signals for hand-foot syndrome or adverse events limiting patients’ daily lives from the authored narratives of patients with cancer, aiming ultimately to use them as safety monitoring support tools for individual patients. Objective: This study was designed to evaluate whether our deep learning models can screen clinically important adverse event signals that require intervention by health care professionals. The applicability of our deep learning models to data on patients’ concerns at pharmacies was also assessed. Methods: Pharmaceutical care records at community pharmacies were used for the evaluation of our deep learning models. The records followed the SOAP format, consisting of subjective (S), objective (O), assessment (A), and plan (P) columns. Because of the unique combination of patients’ concerns in the S column and the professional records of the pharmacists, this was considered a suitable data for the present purpose. Our deep learning models were applied to the S records of patients with cancer, and the extracted adverse event signals were assessed in relation to medical actions and prescribed drugs. Results: From 30,784 S records of 2479 patients with at least 1 prescription of anticancer drugs, our deep learning models extracted true adverse event signals with more than 80% accuracy for both hand-foot syndrome (n=152, 91%) and adverse events limiting patients’ daily lives (n=157, 80.1%). The deep learning models were also able to screen adverse event signals that require medical intervention by health care providers. The extracted adverse event signals could reflect the side effects of anticancer drugs used by the patients based on analysis of prescribed anticancer drugs. “Pain or numbness” (n=57, 36.3%), “fever” (n=46, 29.3%), and “nausea” (n=40, 25.5%) were common symptoms out of the true adverse event signals identified by the model for adverse events limiting patients’ daily lives. Conclusions: Our deep learning models were able to screen clinically important adverse event signals that require intervention for symptoms. It was also confirmed that these deep learning models could be applied to patients’ subjective information recorded in pharmaceutical care records accumulated during pharmacists’ daily work.

薬剤服用歴(薬歴)には患者の主訴が記載されるだけでなく、薬剤師によるアセスメントが経時的に記載されることから、薬剤師の介入による患者の転帰が追跡できる可能性がある。今回、在宅患者に対し薬剤師が医師と連携して服用薬の減薬や医薬品の適正使用推進に取り組んだ事例を対象とし、経時的に記録された薬歴をもとに、薬剤師介入後のフォローアップ実施状況や患者アウトカムの変化について調査した。対象は、株式会社ナカジマ薬局において在宅医療対応件数の多い7店舗で2020年4月～2021年12月に薬歴が記録された当該患者366例とした。調査の結果、薬剤師の介入内容として最も多かったのは「症状の発生に対する介入で」あり、介入後の転帰は半数以上で症状の改善が認められていた。薬剤師の介入によって症状は安定しているが、投与継続されていた薬剤の中止や減量がなされた事例も多くあり、介入後の転帰は9割以上が症状に変化なく経過していたことから、患者の症状コントロールを保ちながら多剤併用解消の一助になっていたと考えられた。

三者連携による服薬支援に関する問題点を抽出し、その対応策について検討することを目的として、介護スタッフ(CW)・看護師・薬剤師を一堂に会したワークショップ(WS)を開催した。CW 9名、看護師4名、薬剤師8名の計21名がWSに参加し、四つのグループに分けた。各グループで抽出された問題点は「服薬介助に関する問題」、「薬の知識に関する問題」、「薬の管理に関する問題」、「情報把握に関する問題」、「コミュニケーションに関する問題」、「その他の問題」に分類された。また、各グループで検討した対応策が介護施設で実施されているか調査したところ、「施設ごとに気になることはなんでも書ける連絡ノートを作成する」、「バイタル・食事・排泄・水分量のチェックシートを薬剤師に開示する」、「薬剤師とCW同士で自己紹介を行い、CWから会話のきっかけをつくる」、「特定の入居者を選び看護師、CWの連携に薬剤師が参加する」などが実践されていた。

保険薬局の薬剤師による癌薬物療法に関する疑義照会の実態を明らかにすることを目的に、癌連携拠点病院である群馬県立がんセンターの処方箋を応需している保険薬局1店が2015年1月～2018年5月末に扱っていた経口抗癌薬20剤とその支持療法に関する疑義照会がなされた事例440件を対象に検討した。その結果、薬局からの疑義照会による処方変更割合は、経口抗癌薬20剤で平均92.7%と高く、また、「未然回避」「経済的損失の軽減あるいは回避」「精神的不安の軽減あるいは回避」といった薬局プレアボイドが多く行われており、外来癌薬物療法における薬物療法適正化に大きく寄与していることが分かった。

保険薬局を対象とした質問紙調査により、フォローアップに関する法施行後における患者フォローアップの実施状況を調査した。一般社団法人薬局団体連絡協議会に加盟している4団体の法人会員が運営する各薬局の管理薬剤師および同協議会に加盟している4団体の個人会員の薬剤師に調査協力依頼を送付し、318店舗の薬局から回答が得られた。患者フォローアップが義務化されて以降にフォローアップを「行ったことがある」との回答は89.0%を占めており、ほとんどのケースで事前に同意がとられていた。フォローアップの手段としてはほぼすべての薬局が電話を利用していた。医薬品適正使用に役立ったと感じたフォローアップ事例として「副作用の有無やその症状の確認」「アドヒアランス不良またはその懸念に対する薬の服用・使用の確認」「患者が抱いた薬の服用・使用に対する不安への対応」などが挙げられた。

薬局団体連絡協議会の加盟団体に所属する薬剤師、および同団体に所属する薬局経営者が経営する薬局の管理薬剤師にアンケートを行い、リフィル処方箋(R処方箋)の受付状況、R処方箋応需に関する薬局の対応状況、R処方箋に対する不安などについて調査した。全国34都道府県の薬局から377件の回答が得られた。R処方箋に関する質問等を受付けたことが「ある」と答えたのは164件(44%)、R処方箋を応需したことが「ある」と答えたのは116件(31%)であった。応需したことのある薬局の対応状況(複数回答)は、患者初回来局時の対応として、「患者にR処方箋について説明する」と答えたのが98件(84%)、「次回も同じ薬局に来ることが推奨されていると伝える」が100件(86%)、「次回来局予定日を確認する」が109件(94%)、「R処方箋が適切であるか確認する」が101件(87%)などであった。R処方箋に不安が「ある」と答えた割合は回答者全体の79%(297件)であった。

首都圏の急性期病院10施設の薬剤部門にアンケートを行い、「造影剤投与に関する内規やマニュアルの有無」「造影剤副作用リスク因子を有する患者への各施設の対応、薬剤部門の介入」などについて調査した。結果、内規やマニュアルの有無については、院内で統一された内規やマニュアルがあると答えたのが5施設、放射線科で統一された内規やマニュアルがあると答えたのが2施設、内規やマニュアルはないと答えたのが3施設であった。造影剤副作用リスク因子として「副作用の既往」「喘息の既往」「造影剤以外によるアナフィラキシーショックの既往」等を有する患者に対しては、半数以上の施設で取るべき対応が定められていた。薬剤部門の介入として、副作用・喘息既往や薬剤アレルギー既往の聴取が7施設で行われており、副作用予防薬の投与が内規やマニュアルで推奨されているのは4施設であった。